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Metrology Specialist in South Plainfield, NJ at Integrated Resources, Inc

Date Posted: 11/24/2018

Job Snapshot

Job Description

Job Summary Metrology Speciaist reports to and takes direction from the Metrology Manager. The Metrology specialist will be responsible for supporting the development of the metrology program and department to meet the growing needs of our current facility, as well as future facilities. Essential Duties And Responsibilities
  • Oversee and support all approved vendor activities for Calibration, Certification, and Preventative Maintenance (PM) (instrumentation, utilities, EMS, and equipment) for all cGMP areas as well as non-cGMP areas including Manufacturing, QC, and R&D.
  • Collaborate with all departmental end users to coordinate schedules, ensuring all activities are conducted by due dates and assuring compliance with appropriate SOPs.
  • Support the review of all calibration, PM, and certification documents as a Subject Matter Expert (SME) in order to identify and initiate Out Of Tolerance (OOT) investigations as needed.
  • Support the OOT investigation process with all departmental end users and collaborate with QA to ensure all investigations and / or CAPA procedures are met.
  • Support all SOPs relating to Calibration, Certification, and PM for all equipment and instruments. This includes revisions to current SOPs based on changes in industry guidelines and regulations, as well as support the generation of new SOPs as needed for new equipment (Continuous improvement).
  • Support development and execute Calibrations and specified PM tasks as the capabilities are established in-house.
Education and/or Experience Minimum of 3 years Pharmaceutical or Regulated industry experience in Calibration / Metrology
ISA Level I certification preferred (or equivalent training and/or certifications)
Minimum of 3 years Pharmaceutical or Regulated industry experience in Calibration / Metrology
ISA Level I certification preferred (or equivalent training and/or certifications)
Other special projects and/or duties may be assigned by Management.
Work as a team member to establish and support calibration / metrology program for tracking, scheduling, and management. Take a lead role in developing and uploading into a MMS, as well as maintaining and managing the MMS ongoing.
Establish good working relationships with other departments.
Strategically work with Metrology and Facilities management.